Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-24 @ 11:24 PM
Ignite Modification Date: 2025-12-25 @ 9:09 PM
NCT ID: NCT01807156
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT01807156
Study Brief: Phase II Trial of Tivozanib in Advanced Hepatocellular Cancer
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tivozanib Patients would receive Tivozanib 1.0 mg/day orally, 3 weeks on, one week off, for one cycle starting day 1. If no adverse event is encountered, patients will continue subsequent cycles of Tivozanib 1.5 mg/day orally; 3 weeks on/1 week off, dosing schedule. Patients will continue on treatment until disease progression, unacceptable toxicity, or patient withdrawal from the study. Tivozanib: Oral medication given daily. No placebo. None None 1 7 5 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pulmonary Embolism NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hyperglycemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Liver Function Test Elevation NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Hypertension NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT General disorders None View